Primary Device ID | B707128320050020 |
NIH Device Record Key | 2c870a80-8962-402a-9b89-7519bd204f58 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KIT DUALX LLIF 7-9MM x 0 DEG x 45MM |
Version Model Number | 12832005002 |
Company DUNS | 081021000 |
Company Name | Amplify Surgical, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707128320050020 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-05 |
Device Publish Date | 2025-04-25 |
B70712833005002A0 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Lateral Width: 46.8mm |
B707128330050020 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Collapsed Width (mm): |
B707128320050020 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Collapsed Width (mm): |